[Federal Register Volume 65, Number 222 (Thursday, November 16, 2000)]
[Notices]
[Pages 69318-69319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29285]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.

[[Page 69319]]

    Date and Time: The meeting will be held on December 13, 2000, 8:30 
a.m. to 5:30 p.m. and December 14, 2000, 8 a.m. to 5:30 p.m.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Karen M. Templeton-Somers, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7001, e-mail: 
[email protected], or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), code 12542. 
Please call the Information Line for up-to-date information on this 
meeting.
    Agenda: On December 13, 2000, the committee will discuss: (1) New 
drug application (NDA)20-726/S-006, Femara (letrozole) 
Tablets, 2.5 mg, Novartis Pharmaceuticals Corp., indicated as first-
line therapy in postmenopausal women with advanced breast cancer; and 
(2) NDA 21-240, histamine hydrochloride injection (1 mg/ml), Maxim 
Pharmaceuticals, Inc., indicated for adjunctive use with interleukin-2 
(aldesleukin) in the treatment of adult patients with advanced 
metastatic melanoma that has metastasized to the liver. On December 14, 
2000, the committee will discuss: (1) Biologics license application 
(BLA) 99-0786, Campath, (alemtuzumab), Millenium and Ilex 
Partners, LP., and Millenium Pharmaceuticals, indicated for the 
treatment of patients with chronic lymphocytic leukemia who have been 
treated with alkylating agents and who have failed fludarabine therapy; 
and (2) single patient exemptions to the use of nonapproved oncology 
drugs and biologics.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by December 6, 
2000. Oral presentations from the public will be scheduled between 
approximately 8:45 a.m. and 9:15 a.m., and 1:30 p.m. and 1:45 p.m. on 
December 13, 2000, and between approximately 8:15 a.m. and 8:45 a.m., 
and 1 p.m. and 1:15 p.m. on December 14, 2000. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before December 6, 2000, 
and submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation. After the scientific presentations, a 30-
minute open public session may be conducted for interested persons who 
have submitted their request to speak by December 6, 2000, to address 
issues specific to the submission or topic before the committee.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 8, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-29285 Filed 11-15-00; 8:45 am]
BILLING CODE 4160-01-F